Edwards ThruPort Systems Manuel D'utilisation

ThruPort Systems
ENDORETURN ARTERIAL CANNULA KITS
Instructions for Use
Directory
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English (EN)
EndoReturn Arterial Cannula Kits
Instructions for Use
CAUTION: Federal law (U.S.A.) restricts this device to sale by, or on the
order of, a physician.
See Figures at the end of the Instructions for Use.
DESCRIPTION
The ThruPort EndoReturn arterial cannula and 19 Fr (6.3 mm) arterial cannula kits
include a wire-reinforced cannula (with or without hemostasis valve), an
introducer, a guidewire, and a connector hub. The ThruPort catheter introducer
sheath kit includes a wire-reinforced cannula with hemostasis valve, an
introducer, and a guidewire. The cannulae have a wire-reinforced section to
provide kink resistance and flexibility, tapered tips to aid in insertion and
advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in.
(9.5 mm) barbed connector, and a hemostasis valve (available on some versions)
that allows passage of catheters, such as the ThruPort EndoClamp aortic catheter.
The introducers accept a 0.038 in. (0.97 mm) guidewire and are marked to simplify
assembly and indicate alignment. On some versions, a connector hub secures and
immobilizes the introducer within the cannula for easier, one-person insertion of
the cannula/introducer assembly. A lubricious coating is applied to the surface of
the cannula body. This coating is intended to provide a lubricious surface effective
for the duration of the intended use of the cannula, thereby easing both the
insertion and retraction of catheters and introducers (see Figures 1, 2, and 3).
IN VITRO TEST RESULTS
See Figure 4 at the end of the Instructions for Use.
HOW SUPPLIED
Supplied sterile and non-pyrogenic in undamaged package. Do not use if device
shows signs of damage (i.e., cuts, kinks, crushed areas, leakage), or if package is
damaged or open as this may indicate compromised sterility and/or product
damage.
CONTENTS
1 - introducer
1 - EndoReturn arterial cannula, 19 Fr (6.3 mm) arterial cannula, or catheter
introducer sheath
1 - 0.038 in. (0.97 mm) guidewire (J-tip, 3 mm)
1 - connector hub (available in some versions)
Effective or usable length on this device is for reference only. Actual
length may vary.
INDICATIONS FOR USE
EndoReturn Arterial Cannula and 19 Fr (6.3 mm) Arterial Cannula
The EndoReturn arterial cannula and 19 Fr (6.3 mm) Arterial Cannula are indicated
for patients undergoing cardiopulmonary bypass. They are intended to deliver
oxygenated blood for cardiopulmonary bypass during surgery. The EndoReturn
arterial cannula with hemostasis valve also allows the hemostatic introduction
and removal of vascular catheters such as the ThruPort EndoClamp aortic catheter.
Catheter Introducer Sheath
The catheter introducer sheath with hemostasis valve is indicated for patients
requiring introduction of catheters. It is intended for the hemostatic introduction
and removal of vascular catheters such as the ThruPort EndoClamp aortic catheter.
CONTRAINDICATIONS
Do not use the EndoReturn arterial cannula, 19 Fr (6.3 mm) arterial cannula, or
catheter introducer sheath if the patient has severe peripheral atherosclerosis or is
otherwise contraindicated for cardiopulmonary bypass.
COMPLICATIONS
The following complications may occur during or following use of the EndoReturn
arterial cannula, 19 Fr (6.3 mm) arterial cannula, or catheter introducer sheath:
• Injury to vessel and/or aorta, including perforation
• Plaque embolization
• Wound infection/sepsis
• Pain at insertion site
• Hematoma
• Arterial thrombosis
• Arterial dissection
• Death
WARNINGS AND PRECAUTIONS
Ensure proper levels of anticoagulant therapy are maintained prior to
insertion of the cannula and throughout cardiopulmonary bypass, to
reduce the risk of complications due to thrombus formation on or within
the cannula, and in the blood stream.
This device is designed, intended, and distributed for single use only. Do
not re-sterilize or reuse this device. There are no data to support the
sterility, nonpyrogenicity, and functionality of the device after
reprocessing.
Products are known to contain phthalates, which may be found in device
materials containing plasticizers such as DEHP and BBP. High exposure to
such phthalates during medical treatments in children and pregnant or
nursing women may raise a concern. A review of available data and
literature supports the conclusion that the benefits outweigh the overall
residual risk.
Proper surgical procedures and techniques are the responsibility of the
medical profession. Described procedures are provided for informational
purposes only. Each physician must determine the appropriate use of
this device for each patient based on medical training, experience, the
type of procedure employed, and the benefits and risks associated with
device use.
INSTRUCTIONS FOR USE
INSPECTION PRIOR TO USE
Before using the EndoReturn arterial cannula, 19 Fr (6.3 mm) arterial cannula, or
catheter introducer sheath, verify that the cannula is not damaged or kinked, that
the lumen is patent, and that the hemostasis valve (available on some versions)
opens and closes completely. If damaged, DO NOT USE.
PREPARATION FOR USE
1. Administer appropriate anticoagulant therapy to the patient.
2. Generously wet the cannula with sterile saline to activate the lubricious
coating.
3. Insert the tip of the introducer into the barbed connector or hemostasis valve
(catheter introducer sheath only). Advance until introducer tip extends 2 cm or
more beyond the distal cannula tip.
4. Advance the connector hub (available on some versions) on the introducer
over the barbed connector. This secures and immobilizes the introducer within
the cannula.
5. Ensure that the hemostasis valve (available on some versions) is completely
sealed to prevent backbleeding during insertion.
INSERTION TECHNIQUE
1. Insert the guidewire into the introducer until the tip of the guidewire is just
inside the tip of the introducer. The guidewire should not extend beyond the
tip of the introducer.
2. While maintaining guidewire position, advance the cannula/introducer
assembly into the artery a short distance. Ensure that the cannula, introducer
and connector hub maintain appropriate alignment with each other.
WARNING: If increased resistance is felt at any time upon insertion or
removal of the guidewire, dilators, introducer, or cannula, stop and
investigate the cause before continuing. Inability to easily advance
or remove these devices may indicate vascular disease or injury.
Closely examine the device position within the vessel using
fluoroscopy and/or transesophageal echocardiography (TEE) prior to
proceeding to minimize the risk of vessel damage.
3. Advance the guidewire.
4. Use fluoroscopy and/or TEE as necessary during advancement and positioning.
5. Maintain guidewire position while advancing the cannula/introducer
assembly into the artery.
WARNING: Failure to properly advance the introducer/cannula or
introducer/sheath over a previously advanced guidewire may result
in vessel perforation and/or dissection.
6. While holding the cannula/introducer assembly in place, slowly withdraw the
guidewire into the introducer and completely remove the guidewire.
7. While holding the cannula and connector hub in place, withdraw the
introducer until it is clear of the clamp site.
8. Clamp at the cannula clamp site.
CAUTION: Wire reinforced cannulae should only be clamped in the
non-reinforced section located at the connector end to avoid cannula
damage and compromised product performance.
1 of 28
9. Remove the introducer and connector hub. Fully tighten hemostasis valve
(available on some versions) and, if necessary, vent air by briefly removing the
tubing clamp and opening the hemostasis valve.
10. For the EndoReturn arterial cannula and 19 Fr (6.3 mm) arterial cannula only,
connect the arterial tubing of the bypass circuit to the cannula ensuring that
no air is introduced into the system. Advance the tubing over the barbed
connector all the way to the flange.
11. Remove the tubing clamp.
To insert or remove the ThruPort EndoClamp aortic catheter, follow
the catheter Instructions for Use.
CAUTION: When inserting or withdrawing catheters, occlusion of the
arterial inflow lumen may occur. Failure to reduce arterial inflow rate
could cause extremely high pressures and tubing disruptions.
CAUTION: Ensure that catheters, introducers and guidewire are
removed or clear of the clamp site before clamping to prevent
damage to these devices and compromised device performance.
WARNING: Prior to initiating cardiopulmonary bypass, completely
expel air from system. Failure to eliminate air from the system could
result in an air embolus.
WARNING: Ensure that the hemostasis valve is fully sealed at all
times to prevent introduction of air, which may result in an air
embolus.
WARNING: As cardiopulmonary bypass is initiated, increase flow rate
gradually. Sudden pressure spikes may result in disruption of cannula
placement in vessel.
WARNING: Do not allow pump flow rates that cause the line or
oxygenator outlet pressure to exceed 350 mmHg. High blood
pressures will increase the risk of blood hemolysis and tubing
disruptions.
WARNING: Secure the cannula in position in the artery with a suture.
Failure to do so may result in disruption of bypass.
12. Dispose of used product in accordance with established hospital protocols for
biohazards to minimize risk of exposure.
STORAGE AND HANDLING
Store sterile packaged device in a cool dry place until ready for use. Do not expose
to organic solvents, ionizing radiation, or alcohol-based fluids.
TECHNICAL ASSISTANCE
For technical assistance, please call Edwards Technical Support at the following
telephone numbers:
Inside the U.S. and Canada (24 hours): 800.822.9837
Outside the U.S. and Canada (24 hours): 949.250.2222
In the UK: 0870 606 2040, Option 4
In Ireland: 01 8211012, Option 4
Edwards, Edwards Lifesciences, the stylized E logo, EndoClamp, EndoReturn, and
ThruPort are trademarks of Edwards Lifesciences Corporation. All other trademarks
are the property of their respective owners.
Made in the U.S.A.
Français (FR) French
Kits de canule artérielle EndoReturn
Mode d'emploi
AVERTISSEMENT : Federal law (U.S.A.) restricts this device to sale by, or
on the order of, a physician.
Voir les figures à la fin du mode d'emploi.
DESCRIPTION
Le kit de canule artérielle ThruPort EndoReturn de 6,3 mm (19 Fr) comprend une
canule à renforcement métallique (munie ou non d'une valve hémostatique), un
introducteur, un fil-guide et une embase de connecteur. Le kit de la gaine
d'introduction de cathéter ThruPort comprend une canule à renforcement
métallique munie d'une valve hémostatique, un introducteur et un fil-guide. Les
canules comportent une partie à renforcement-métallique qui permet de résister
aux torsions et augmente la souplesse du dispositif, des embouts fuselés pour
aider à l'insertion et à la progression dans l'artère fémorale, un site de clampage
non renforcé, un connecteur cannelé de 9,5 mm (3/8 po) et une valve
hémostatique (disponible dans certaines présentations) permettant le passage de
cathéters comme le cathéter aortique ThruPort EndoClamp. Les introducteurs sont
compatibles avec un fil-guide de 0,97 mm (0,038 po) et ils comportent des repères
afin de simplifier l'assemblage et de vérifier l'alignement. Dans certaines versions,
l'embase de connecteur fixe et immobilise l'introducteur dans la canule, pour
faciliter l'insertion de l'ensemble canule/introducteur par une seule personne. Un
revêtement lubrifié est appliqué à la surface du corps de la canule. Ce revêtement
est destiné à lubrifier efficacement la surface pour la durée d'utilisation prévue de
la canule, facilitant ainsi l'insertion et le retrait des cathéters et des introducteurs
(se reporter aux Figures 1, 2 et 3).
RÉSULTATS D'UN TEST IN VITRO
Consulter la figure 4 à la fin du mode d'emploi.
PRÉSENTATION
Conditionné de manière stérile et apyrogène si l'emballage est intact. Ne pas
utiliser en présence de détériorations du dispositif (coupures, torsions,
écrasement, fuite) ou si l'emballage est ouvert ou endommagé, car cela peut
signifier que le produit n'est plus stérile et/ou qu'il est défectueux.
CONTENU
1 - introducteur